Effect of Quetiapine on Negative Symptoms and Cognition
Phase 3
Completed
- Conditions
- Schizophrenia
- Registration Number
- NCT00305422
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of the study is to investigate the outcome on negative symptoms of schizophrenic patients during therapy with quetiapine or risperidone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- Signed informed consent
- men and women aged 18 to 65 years with diagnosis of schizophrenia
- score of at least 4 CGI, PANSS negative subscale score > 21
- fulfil the criterion to be right-handed for inclusion in the fMRI investigations
Exclusion Criteria
- Substance or alcohol dependence
- female patients who are pregnant, lactating or at risk of pregnancy
- history of organic CNS-trauma, epilepsy, meningoencephalitis, psychosurgery, instable somatic conditions
- risk of suicide or aggressive behaviour
- history of electroconvulsive therapy, Parkinson's disease, Prolactin-dependent tumor
For the subset of subjects for the fMRI investigations the following additional exclusion criteria is valid as:
- existence of metal in the body as by cardiac pacemaker, coil, total prosthesis, metal splinter, metal articulation, metal balls.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Clinical efficacy of both neuroleptics, especially with regard to cognitive deficits and functional brain activation between baseline and week 12
- Secondary Outcome Measures
Name Time Method Change from baseline in PANSS negative symptom total score, PANSS subscores, CGI, CGI-severity of illness, HAMD, Simpson-Angus-Scale, BPRS, specific PANSS items , Startle reflex.
Trial Locations
- Locations (1)
Research Site
🇩🇪Munich, Germany